Mode
Text Size
Log in / Sign up
Phase 3 N=808 Randomized Treatment

BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)

Hypertension

Enrolled (actual)
808
Serious AEs
2.0%
Results posted
Apr 2010
Primary outcome: Primary: Change in Systolic Blood Pressure From Baseline to Week 12 — -19.9; -20.8 mm Hg — p=0.395

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
losartan potassium (+) hydrochlorothiazide (Drug); Comparator: Valsartan (+) Hydrochlorothiazide (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Organon and Co
Primary completion
Apr 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Systolic Blood Pressure From Baseline to Week 12
-19.9; -20.8 0.395
PRIMARY
Change in Diastolic Blood Pressure From Baseline to Week 12
-10.6; -10.5 0.935
SECONDARY
Change in Systolic Blood Pressure From Baseline to Week 6
-16.7; -18.2 0.153
SECONDARY
Change in Diastolic Blood Pressure From Baseline to Week 6
-8.4; -9.1 0.343
SECONDARY
Number of Patients Achieving Target Blood Pressure at Week 6
253; 241; 140; 104 0.118
SECONDARY
Number of Patients Achieving Target Blood Pressure at Week 12
278; 253; 94; 79 0.662
SECONDARY
Time to Achieve Target Blood Pressure
62.3; 57.3 0.020 sig
SECONDARY
Change in Uric Acid From Baseline to Week 6
0.3; 21.7 <0.001 sig
SECONDARY
Change in Uric Acid From Baseline to Week 12
-0.4; 29.9 <0.001 sig
SECONDARY
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
0.8; 0.6 0.899
SECONDARY
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
-0.3; 0.5 0.218
SECONDARY
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
-1.8; -0.1 0.386
SECONDARY
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12
-0.7; -0.0 0.725

Summary

To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.

Eligibility Criteria

Inclusion Criteria

  • An Adult Patient 18 to 75 Years Of Age
  • Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:
  • Either systolic or diastolic blood pressure > 140/90 mm Hg up to 180/110 mm Hg (inclusive)
  • Either systolic or diastolic blood pressure > 130/80 mm Hg up to 160/100 mm Hg (inclusive) for diabetic patients
  • Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:
  • Surgically sterilized female
  • Postmenopausal female > 45 years of age with > 2 years since her last menses
  • Non-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy [either 2 barrier methods or a barrier method plus a hormonal method]; or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication; or (3) only engage in heterosexual activity with surgically sterilized male partner(s) throughout the study starting with Visit 1 and for 14 days after the last dose of study medication
  • Patient judged to be in otherwise good, stable health on the basis of medical history and physical examination

Exclusion Criteria

  • Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)
  • Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
  • Patient taking allopurinol
  • Patient Previously Shown To Be Intolerant To Any Component Of Losartan Valsartan, Or HCTZ Or With A Documented History Of Angioedema/Anaphylaxis
  • Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Umol/L Or Creatinine Clearance 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2 Times Above The Normal Range, Serum Potassium 5.5 Meq/L
  • Patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months
  • Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that need a chronic inflammatory therapy such as prednisone or other steroid agents
  • Patient with symptomatic heart failure (classes 3 and 4)
  • Patient with a history of stroke within the last 6 months
  • Patient with coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction, all that occurred less than 6 months prior to visit 1 or has unstable angina
  • Patient having participated in an investigational drug program in the last 30 days (prior to Visit 1)
  • Unable or unwilling to comply with the protocol, therefore likely to leave the trial before its completion
  • Patient intends to move or to vacation away from home during the course of the study which would interfere with the scheduled visits.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00546754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search